FDA (Devices) recall action 84772
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
The product do not meet certain internal testing specifications.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ethicon, Inc. is recalling 133 units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.
Ethicon, Inc. is recalling three units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.
Ethicon, Inc. is recalling 660 units of Stratafix Spiral PDS Plus Violet sutures because the product did not meet internal testing specifications.